About
Danièle Grondines has over 25 years of experience in quality assurance and regulatory affairs in the medical device industry. She has served as a lead auditor for notified bodies in Asia, the United States, and Canada. She has worked in the medical industry in the development and manufacturing of active medical devices and electrophysiology software. Danièle specializes in medical device regulation in various jurisdictions (Canada, the United States, Europe, the United Kingdom, Australia, and Japan). She also advises on the management of personal health data and assists startups in developing effective regulatory strategies.
- Strategic Planning
- Standardization and Certification
- Project Management and Implementation Monitoring
- Performance Measurement and Continuous Improvement
- Process Optimization
- Cybersecurity
- Strategic Planning in Regulatory Affairs
- Consulting and Support Throughout a Medical Device Certification Project
- Regulatory Assistance for Active and Inactive Medical Devices and Software for the Canadian, US, European, and UK Markets
- Information Security and Cybersecurity Requirements Assistance for Multiple Markets
- Clinical Risk Management for Medical Devices and Healthcare Information Systems
- Conducting Internal Audits for Critical Medical Device Manufacturers and Suppliers
- Support in the development, approval, and post-market surveillance of medical devices.
- Conducting internal audits for medical device manufacturers according to ISO 13485:2016, MDSAP, MDR/MDD, UKCA standards, as well as regulations in Canada, the United States, Australia, and Japan.
- Support for regulatory submissions to the FDA, Health Canada, MHRA, NHS, European notified bodies, and international authorities. Also provides advice on the management and protection of patients’ personal data.